510(k) Report

Devices descending from K963012

5 later devices reach Bioject Needle-Free Vial Adapter (13MM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070584Smart-RodDuoject Medical Systems, Inc.20082—
+1K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc.20043—
+1K041564Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc.20040—
+2K133097E-Z LinkDuoject Medical Systems, Inc.20141—
+3K161800OnSite-IVPharmc, LLC20160—